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Read all of this lea�et carefully before you start taking this medicine because it contains important information for you.- Keep this lea�et. You may need to read it again.- If you have any further questions, ask your doctor or pharmacist.- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.- If you get any side e�ects, talk to your doctor or pharmacist. This includes any possible side e�ects not listed in this lea�et. See section 4.

What is in this lea�et1. What Telfast is and what it is used for2. What you need to know before you take Telfast3. How to take Telfast4. Possible side e�ects5. How to store Telfast6. Contents of the pack and other information

1. What Telfast is and what it is used forTelfast contains fexofenadine hydrochloride, which is an antihista-mine.Telfast 120 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever(seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.Telfast 180 mg is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes.

2. What you need to know before you take TelfastDo not take Telfastif you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)Warnings and precautionsTalk to your doctor or pharmacist before taking Telfast if: -you have problems with your liver or kidneys, -you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat, -you are elderly.If any of these apply to you, or if you are not sure, tell your doctor before taking TelfastOther medicines and TelfastTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Indigestion remedies containing aluminium and magnesium may a�ect the action of Telfast by lowering the amount of medicinal product absorbed.It is recommended that you leave about 2 hours between the time that you take Telfast and your indigestion remedy.Pregnancy and breast-feedingAsk your doctor or pharmacist for advice before taking any medicine.Do not take Telfast if you are pregnant, unless necessary.Telfast is not recommended during breast-feeding.Driving and using machinesTelfast is unlikely to a�ect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.

3. How to take TelfastAlways take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.For adults and children aged 12 years and overThe recommended dose is one tablet daily.Take your tablet with water before a meal.If you take more Telfast than you shouldIf you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.Symptoms of an overdose in adults are dizziness, drowsiness, fatigue and dry mouth.If you forget to take TelfastDo not take a double dose to make up for a forgotten tablet.Take the next dose at the usual time as prescribed by your doctor.

If you stop taking TelfastTell your doctor if you want to stop taking Telfast before you have �nished your course of treatment.If you stop taking Telfast earlier than planned, your symptoms may return.If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side e�ectsLike all medicines, this medicine can cause side e�ects, although not everybody gets them.Tell your doctor immediately and stop taking Telfast if you experience:- swelling of the face, lips, tongue or throat and di�culty breathing, as these may be signs of a serious allergic reaction.Common side e�ects (may a�ect up to 1 in 10 people):- headache- drowsiness- feeling sick (nausea)- dizziness.Uncommon side e�ects (may a�ect up to 1 in 100 people):- tiredness- sleepiness.Additional side e�ects (frequency not known: cannot beestimated from the available data) which may occur are:- di�culty sleeping (insomnia)- sleeping disorders- bad dreams- nervousness- fast or irregular heart beat- diarrhoea- skin rash and itching- hives- serious allergic reactions which can cause swelling of the face, lips, tongue or throat, �ushing, chest tightness, and di�culty breathing.Reporting of side e�ectsIf you get any side e�ects, talk to your doctor, pharmacist or nurse. This includes any possible side e�ects not listed in this lea�et.

5. How to store TelfastDo not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last dayof that month.Store below 25 °C, in a dry place.

6. Contents of the pack and other informationWhat Telfast 120 mg contains-The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride equivalent to Fexofenadine base 112mg.What Telfast 180 mg contains-The active substance is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride equivalent to Fexofenadine base 168 mg.

The other ingredients are:- Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.- Film coating: hypromellose, povidone, titanium dioxide, colloidal anhydrous silica, macrogol 400, and iron oxide

Contents of the pack:Carton box containing 1,2,3 or 6 (PVC/PE/PVDC/AL) blisters each of 10 tablets & an inner lea�et.

Keep all medicines out of reach of children

Produced by SANOFI Egypt s.a.e.Under license of sano�-aventis/ Franceand its a�liate sano�-aventis limited / UK

This insert was last approved in August 2014

S4

Fexofenadine hydrochloride

Brand name: Telfast tabletsArtwork type: Lea�etVersion number (Revision): S4 Bar code: 1306 SAP identi�cation no.: E043047 Country: EgyptDate: 05.09.2013Designer: Gamal HabibDimensions: 300 x 175 mmpackaging machine: MarchesiniLogo version: A1Minimum point size of text: 8 Pt.Colors:Re�ex blue

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"EXP"

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Film-coated tablets

E043047 - Pamph Telfast Tab 120/180mg S@n S4 N Des

This document has been digitally signed by the following people within the VISTAlink system,

following the sanofi-aventis group guidelines.

Plant: CAIRO- EGYPT

Packaging material code: E043047

Packaging material name: Pamph Telfast Tab 120/180mg S@nS4 N Des

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VISTAlink folder number: 1317429

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Reason Signed by Date

Market regulatory validation Reham Alassily (Egyptregulatory affairs team) 28/09/2014 16:29:09

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Plant final technical validation Mohamed Zaki (Cairo packagingteam) 01/11/2014 16:55:23

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